(12 days)
SMart Offset Stapes Piston Prosthesis: Bridging the stapes in cases of otosclerosis: specifically for surgical revision in patients with a shortened incudal process, and also in primary surgery with this anatomical condition.
SMart ISJ Prosthesis: Bridging defects at the long incudal process with otherwise intact mobile chain.
SMart Offset Stapes Piston: Middle Ear Piston, Partial Ossicular Replacement Prosthesis. Utilizes nitinol wire embedded in a fluoroplastic shaft. Offered in lengths of 3.0 mm through 6.0 mm (functional length) and shaft diameters of .4, .6, .8 mm. Offset lengths between 1mm and 2mm. Supplied sterile.
SMart ISJ Prosthesis: Partial Ossicular Replacement Prosthesis. Utilizes nitinol shaft and loops welded to a titanium bell. Offered in lengths of offset of 2.25 mm, 3.25 mm. Supplied sterile.
The provided text does not contain information about acceptance criteria or a study proving device performance in the context of a diagnostic or AI-powered medical device. The documents are 510(k) notifications for two medical devices: the SMart™ Offset Stapes Piston Prosthesis and the SMart™ ISJ Prosthesis.
These notifications focus on demonstrating substantial equivalence to predicate devices rather than proving a specific performance against acceptance criteria through a clinical study or AI performance evaluation. The substantial equivalence argument is based on similar intended use, comparable materials (with acknowledged differences whose biocompatibility is asserted), and similar design features.
Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria and a study that proves the device meets them, as this kind of information is not present in the provided FDA 510(k) summary. The document does not describe:
- Acceptance criteria in terms of numerical performance targets (e.g., sensitivity, specificity, accuracy).
- A study (clinical or otherwise) designed to measure the device's performance against such criteria.
- Sample sizes for test or training sets, as it's not an AI/diagnostic device.
- Expert ground truth establishment, adjudications, or MRMC studies, as these relate to performance evaluation of diagnostic tools, which these prostheses are not.
- Standalone algorithm performance as there is no algorithm.
- Type of ground truth (pathology, outcomes data) as this relates to diagnostic accuracy.
- Training set sample size or how its ground truth was established, as this is irrelevant for a physical medical implant.
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NOV 2 4 2003
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Food and Drug Administration 510(k) Notification - SMart Partial Ossicular Replacement Prosthesis November 10, 2003
510(k) Summary of Safety and Effectiveness
| Trade Name: | SMart Offset Stapes Piston prosthesis |
|---|---|
| Common Name: | Middle Ear Piston |
| Classification Name: | Partial Ossicular Replacement Prosthesis (9 |
| 874.3450) | |
| Official Contact: | Gregory Sredin |
| Manager of Regulatory Affairs | |
| Gyrus ENT | |
| 2925 Appling Road | |
| Bartlett, TN 38133 | |
| Telephone: | (901) 373-0200 |
| Telefax: | (901) 387-3914 |
| Date Prepared: | October 31, 2003 |
The SMart Offset Stapes Piston is substantially equivalent to the Angular Piston sold by Heinz Kurz GmbH Medizintechnik
Intended Use
The SMart Offset Stapes Piston has the same intended use as the Angular Piston: bridging the stapes in cases of otosclerosis: specifically for surgical revision in patients with a shortened incudal process, and also in primary surgery when this anatomical condition is present.
Material
The SMart Offset Stapes Piston differs from the predicate device in the material used. The predicate device used titanium whereas the SMart Offset Stapes Piston utilizes nitinol wire embedded in a fluoroplastic shaft. This is the same combination of materials that is utilized in the Gyrus ENT SMart Piston that was cleared by the FDA in K003214. (See Exhibit 6)
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510(k) Summary of Safety and Effectiveness
| Trade Name:Common Name:Classification Name: | SMart ISJ prosthesisPartial Ossicular Replacement ProsthesisPartial Ossicular Replacement Prosthesis (S 874.3450) |
|---|---|
| Official Contact: | Gregory SredinManager of Regulatory AffairsGyrus ENT2925 Appling RoadBartlett, TN 38133 |
| Telephone:Telefax: | (901) 373-0200(901) 387-3914 |
| Date Prepared: | October 31, 2003 |
The SMart ISJ Prosthesis is substantially equivalent to the Angular Prosthesis (Plester) sold by Heinz Kurz GmbH Medizintechnik
Intended Use
The SMart ISJ Prosthesis has the same intended use as the Angular Prosthesis: bridging defects at the long incudal process with otherwise intact mobile chain.
Material
The SMart ISJ Prosthesis differs from the predicate device in the material used. The predicate device uses gold and titanium whereas the SMart Offset Piston utilizes nitinol shaft and loops welded to a titanium bell.
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Table of Similarities and Differences
SMart Offset Stapes Piston vs. Angular Piston
| SMArt Offset Stapes Piston(Gyrus ENT) | Angular Piston(Heinz Kurz GmbH Medizintechnik) | Similarities or Differences | |
|---|---|---|---|
| Intended Use | Bridging the stapes in cases of otosclerosis:specifically for surgical revision in patientswith a shortened incudal process, and also inprimary surgery when this anatomicalcondition is present | Bridging the stapes in cases of otosclerosis:specifically for surgical revision in patients witha shortened incudal process, and also inprimary surgery when this anatomical conditionis present | Same. No new indications for use. |
| Loop material | Nitinol | Titanium | Different. Nitinol is also biocompatibleand was chosen for its shape-memorycharacteristics that allow the surgeonto close the open loops around theincus using a heat source in addition tomanual crimping. |
| Shaft material | Fluoroplastic | Titanium | Different. Fluoroplastic has a longhistory as an implant material and waschosen for its ability to be moldedaround the shaft of the loops |
| Lengths | 3.0 mm through 6.0 mm (functional length) | 6.0 mm (overall length) | Comparable. The SMart is offered inlengths of 3 - 6 mm, in 1-mmincrements to assist the surgeon inselecting the optimal length for hispatient |
| Shaft Diameter | .4, .6, .8 mm | .4, .6 mm | Comparable. In addition to the .4 and.6 mm shaft the SMart is also offeredin a .8 mm diameter for the surgeonseeking more stability. Similar shaftdiameters are found in the Gyrus ENTSMart Piston (K003214) |
| Offset | 1mm to 2mm | 2 mm | Comparable. The SMart piston will beoffered in offset lengths between 1 and2 mm to allow the surgeon greaterflexibility in selecting the appropriatesize for his patient. |
| Sterile | Sterile | Same |
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SMart ISJ prosthesis vs. Angular Prosthesis
| SMart ISJ Prosthesis(Gyrus ENT) | Angular Prosthesis(Heinz Kurz GmbH Medizintechnik) | Similarities or Differences | |
|---|---|---|---|
| Intended Use | Bridging defects at the long incudalprocess with otherwise intact mobile chain. | Bridging defects at the long incudal processwith otherwise intact mobile chain. | Same. No new indications for use. |
| Loop material | Nitinol | Titanium | Different. Nitinol is alsobiocompatible and was chosen for itsshape-memory characteristics thatallow the surgeon to close the openloops around the incus using a heatsource in addition to manualcrimping. |
| Bell material | Titanium | Titanium/Gold | Same |
| Lengths of offset | 2.25 mm, 3.25 mm | 2.25 mm, 3.25 mm | Same |
| How supplied | Sterile | Sterile | Same |
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol featuring three human profiles facing to the right, with flowing lines representing hair or clothing.
Public Health Service
NOV 2 4 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Gyrus, ENT L.L.C. c/o Gregory Sredin Manager of Regulatory Affairs 2925 Appling Road Bartlett, TN 38133
Re: K033554
Trade/Device Name: SMart™ Offset Stapes Piston Prosthesis SMart™ ISJ Prosthesis
Regulation Number: 21 CFR 874.3450 Regulation Name: Partial ossicular replacement prosthesis Regulatory Class: Class II Product Code: ETB Dated: November 10, 2003 Received: November 12, 2003
Dear Mr. Sredin:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Gregory Sredin
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
A. Paizi Kiremthed
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Food and Drug Administration 510(k) Notification – SMart Partial Ossicular Replacement Prosthesis November 10, 2003
510(k) Number: Device Name:
SMart Offset Stapes Piston Prosthesis
Indications for Use:
- . Bridging the stapes in cases of otosclerosis: specifically for surgical revision in patients with a shortened incudal process, and also in primary surgery with this anatomical condition.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ✓
Counter
(Per 21 CFR 801.109)
Keren Golan
(Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devise
510(k) Number K033554
OR
Over-the-
(Optional Format 1-2-96)
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Food and Drug Administration 510(k) Notification - SMart Partial Ossicular Replacement Prosthesis November 10, 2003
510(k) Number: Device Name:
SMart ISJ Prosthesis
Indications for Use:
- Bridging defects at the long incudal process with otherwise intact mobile chain. ●
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | ✓ |
|---|---|
| Counter | |
| (Per 21 CFR 801.109) |
OR
Over-the-
(Optional Format 1-2-96)
Division of Ophthalmic Ear,
Nose and Throat Devises
510(k) Number K033554
§ 874.3450 Partial ossicular replacement prosthesis.
(a)
Identification. A partial ossicular replacement prosthesis is a device intended to be implanted for the functional reconstruction of segments of the ossicular chain and facilitates the conduction of sound wave from the tympanic membrane to the inner ear. The device is made of materials such as stainless steel, tantalum, polytetrafluoroethylene, polyethylene, polytetrafluoroethylene with carbon fibers composite, absorbable gelatin material, porous polyethylene, or from a combination of these materials.(b)
Classification. Class II.